Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage

Phase 4

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: CAF+ADM+EMD; Procedure: CAF+ADM

• Registration Number: NCT00720707
• Lead Sponsor: Tabriz University

Brief Summary

The aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .

Detailed Description

coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.Random allocation of the treatment sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.The parameters of the study are as following items: probing depth( PD), clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC) and the patients will be followed up for 6 months.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-02
• Study Completion: 2007-03
• Status Verified: 2008-07
• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-22
• Last Update Submitted: 2008-07-22
• Study First Posted: 2008-07-23
• Last Update Posted: 2008-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Having no systemic disease affecting the periodontium,
• No contraindication for elective surgery,
• Adequate oral hygiene ,
• No previous surgical attempts for root coverage at the studying sites,
• Vital teeth and signing a witness letter.

Exclusion Criteria

• Smoking, presence of a restorations on tooth surface for test and control teeth,
• Pregnancy,
• Being under treatment with steroids,
• Peri-apical infection,
• Indication for antibiotic prophylaxis prior to dental treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(CAF+ADM+EMD)	CAF+ADM+EMD	using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).
(CAF + ADM)	CAF+ADM	root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM)

Primary Outcome Measures

Name	Time	Method
the percentage of root coverage	at baseline, 2 and 6 months after treatment.

Secondary Outcome Measures

Name	Time	Method
clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures	6 months after treatment

Trial Locations

Locations (1)

Faculty of Dentistry- Tabriz University of Medical Sciences; 🇮🇷 Tabriz, East Azerbaijan, Iran, Islamic Republic of